Tony Barnitz

WORK HISTORY

EDUCATION

SKILLS

ABOUT TONY BARNITZ

I am a cell therapy leader with over a decade of experience driving external manufacturing, process development, and technical operations across the product lifecycle – from early-stage research through commercial readiness. I specialize in CDMO oversight, technology transfer, and cross-functional program management, with a proven track record of resolving complex manufacturing challenges and advancing programs toward regulatory milestones. My work spans site-to-site comparability studies, process validation, and direct FDA engagement, including Type B meetings where I have successfully aligned Agency agreement on critical manufacturing strategies.Grounded in a Ph.D. in Immunology from the University of Pennsylvania and postdoctoral research at Dana-Farber Cancer Institute, I bring a deep scientific foundation to every operational challenge. Throughout my career, I have built and led high-performing MSAT and process development teams, established robust person-in-plant programs, and contributed to IND filings and CMC submissions across multiple T cell therapy platforms. I am passionate about translating cutting-edge science into reliable, scalable manufacturing solutions that ultimately deliver life-changing therapies to patients.